Alpha-Tek LLC

FDA Regulatory Profile

Alpha-Tek LLC appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0001-2022, Class I) was initiated on July 16, 2021.

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0001-2022Class IALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, July 16, 2021